Ultrasonography in Diagnosis of Polyneuropathy

Polyneuropathies Clinical Trial

Official title:

Optimization of Ultrasound Sheer Wave Elastography for the Evaluation of Peripheral Nerve Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390527
• Other study ID #: USpolyneuropathy
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• Clinical signs of particular polyneuropathy not explained by other causes

Exclusion Criteria:

• Entrapment or compression neuropathies

• Nerve trauma

• The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.

Related Conditions & MeSH terms

• Polyneuropathies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana, Faculty of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical examination	1) Myotatic reflexes (biceps, triceps, finger flexors, patellar, Achilles, deep abdominal): 1-absent, 2-reduced or 3-present with facilitation.; Muscle atrophy: 1-no atrophy, 2-mild, 3-moderate or4-severe atrophy; Muscle strength of lower and upper limbs with Medical Research Council (MRC) scale (0-5/5): shoulder abduction, elbow flexion and extension, wrist flexion and extension, fingers flexion, extension and abduction, hip flexion, extension, abduction and adduction, knee flexion and extension, ankle dorsal flexion, plantar flexion, eversion and inversion, thumb flexion and extension.; Touch sensation in all dermatomes with cotton wool: 1-normal sensation, 2-mild, 3-severe or 4-absent.	Through study completion, an average 2 years.
Primary	Electrodiagnostic studies	Motor nerve conduction studies in median, ulnar, radial, fibular and tibial: distal motor latency, compound muscle action potential (CMAP) amplitude, duration and area, conduction velocity.; Sensory nerve conduction studies in median, ulnar, superficial radial, superficial fibular and sural nerve: latency, sensory nerve action potential (SNAP) amplitude and velocity	Through study completion, an average 2 years.
Primary	Ultrasonography	Cross-sectional area (CSA) and shear-wave velocity (SV) of: median nerve at wrist, forearm, elbow and upper arm; ulnar nerve at wrist, forearm, elbow and upper arm; radial nerve at elbow and upper arm; vagus nerve; brachial plexus (C5,6 and 7); fibular nerve at capitulum fibulae and popliteal fossa; tibial nerve at the medial malleolus and popliteal fossa; sciatic nerve; sural nerve	Through study completion, an average 2 years.
Primary	Patient history	demographic data: sex, date of birth, height, weight; symptoms duration (months), symptoms, therapy	Through study completion, an average 2 years.